Payment for Subject Participation in Research
The nature, amount, and method of payment or other remuneration should not constitute undue inducement to participate (i.e., the payment should not serve as sufficient inducement for the subject to volunteer).
The IRB will consider the impact participation poses on the daily life of the potential subject. For example, the IRB will consider compensation of subjects for inconvenience posed by the research, such as:
- the time required to participate;
- travel involved and/or parking costs;
- lost time from work,
- babysitters, etc.
Investigators should include provisions in the protocol for addressing these concerns, especially for research that poses little or no direct benefit for the subjects.
Special precautions should be taken when payment is offered to a third party for the participation of someone else in the research. The IRB is concerned that such payments may constitute undue influence from the third party to the actual research participant. For example, a parent may be offered remuneration for volunteering their child to participate in a research project. In these cases, precautions should be taken to clearly separate the payment to the third party from the consent/assent process with the actual research participant. Final approval for participation rests solely with the research participant and their consent/assent takes precedence over that of the person to whom payment is offered.
Payment to research participants for participation in studies is not considered a benefit. Rather, it should be considered compensation for time and inconvenience or a recruitment incentive. The amount and schedule of all payments should be described in the IRB protocol at the time of initial review, including a summary of both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence.
Timing of Payments
Since subjects reserve the right to withdraw their participation from the research without prejudice, payment to subjects should be prorated, i.e., partial participation in a research activity would obligate partial payment. The IRB will review both the amount of the payment, to whom it is offered, and the proposed method of disbursement to ensure that payment for participation does not constitute coercion or undue influence. Investigators should explain the payment schedule in the informed consent document.
Credit for payment should accrue as the study progresses and not be contingent upon the participant completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to participants who withdraw from the study may be paid at the time the study would have been completed had they not withdrawn. For example, in a study lasting only a few days, it would be permissible to allow a single payment date at the end of the study, even to participants who withdraw before completion. However, for a study lasting several months, it would not be permissible to allow a single payment date. Participants who withdraw before completion of the study should receive accrued compensation in a timely manner.
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion is acceptable, providing that such incentive is not coercive. The IRB will determine whether the amount paid as a bonus for completion is reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.
Disclosure of Payments
All information concerning payment, including the amount and schedule of payment(s), should be described in the informed consent document.
Alterations in Payments
Any changes in participant compensation or flexibility of the payment schedule must be reported to the IRB as a modification prior to implementation.
Difference Between Compensation and Reimbursement:
Reimbursement is used when the subject is paid back for travel expenses such as mileage, lodging, food while traveling. Compensation is "payment" for things such as time, discomfort, inconvenience.
Requirements for reimbursement:
Reimbursements must be paid with Oracle Expenditure types found under the Travel Heading. For instructions on how to process a reimbursement please see "Goods and Services Procurement Guide" at http://www.procurement.virginia.edu/main/. You may also call the Procurement Help Desk at 924-4212. The money will not be reportable to the IRS as income, but will be withheld if the subject owes money to the state. You may want to speak to procurement regarding the typically turn around time for reimbursements, so that you are including accurate information in the consent form. Another option for reimbursements is a petty cash fund. Speak with Procurement regarding this option. Please do not state in the consent form that you are "reimbursing" the subject if you do not plan to process the payment under the expenditure type found under the Travel Heading- since the tax ramifications are different.
Requirements for compensation:
Compensation may be given in several different forms. These may include check via oracle, gift cards, petty cash or small gifts such as a food item, pencils/ stickers. The state encourages the use of check via oracle for most payments. However circumstances do allow other methods of compensation in special circumstances if approved by the IRB. If using oracle the expenditure type of Services, Human Subject Payments found under Contractual Services should be used. Please note that the paid amount will be reportable to the IRS as income and will be withheld if the subject owes money to the state. It is critical that the researcher does not imply in the consent form that one is being "reimbursed" if you plan to process the payment via compensation methods, since there are very different tax implications for the subject.
Course Credit as Compensation
For most confidential studies, it is usually acceptable for the researcher to recruit their own students as long as they will have no knowledge of who decided to participate. In some cases, the Board may ask that a third party be used to announce the study to the class. For example, if you have a research assistant or another researcher on the project who does not influence grades in the class, it may be more appropriate for that individual to invite the class to participate in the study. If using a third party is not an option, another option would be to provide IRB-approved flyers about the study placed in box and available for pick up on the way out of the classroom and outside the view of the researcher/professor or perhaps sending out an IRB-approved broadcast email to the students The purpose of these measures is to remove the teacher as much as possible from the participants without compromising the data collection.
If students will be offered extra credit as compensation for participation in a confidential study, an alternative extra credit option must also be available if study participation is declined. The students should be provided a way to submit their extra credit that does not identify them to the researcher. It is suggested that a third party who is grading the course but is not a part of the study (such as a teaching assistant) or another researcher who does not have the same influence over the students, be asked to collect information about the extra credit assignments.
The Board does not have a cap on compensation amounts but rather reviews the amount of compensation provided per each individual protocol as compared to the study population being recruited, the amount of time required for participation, and the required study procedures to determine if a given compensation amount is coercive for the participant in a particular study or not.